EMA’s Revised Guide On Additional Risk Minimization ‘Overly Detailed’

EU Pharma Association Pushes For Greater Use Of Digital Formats

Executive Summary: The European pharma industry federation believes the advice provided in the updated draft EU guideline on additional risk minimization measures is far too detailed, resulting in a lack of focus, information overlap and confusion.

White pills on leaflet about possible side effects and overdose
Risk management of medicines involves activities to identify, characterize, prevent and minimize risks • Source: Alamy

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